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Deviation Writer Pharmaceuticals

Belgium, Braine-L'alleud · Job Posted June 03, 2026
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Job Description

Assignment within the Production Process – B7 (Biologics). Strong need on Downstream Processing (DSP) production deviations, with a significant backlog to manage. New role within the organization: the consultant will report directly to the Hiring Manager or the DSP Production Manager. Mission is 100% focused on deviation management.

Job Responsibility

  • End-to-end management of DSP production deviations, from opening to closure
  • Field investigation: Regular presence in production areas, conducting interviews with technicians and operators, understanding and challenging equipment functioning and process steps
  • Writing of deviations in the Quality System (minor, major, clustered deviations)
  • Close collaboration with cross-functional teams: Production teams, QA / QA Validation, MSAT / QAMSAT, Maintenance / Technical Services
  • Participation in root cause analysis (RCA) and definition of corrective and preventive actions (CAPA)
  • Defense and explanation of technical analyses in front of QA and other stakeholders

Requirements

  • 4–6 years of experience in a similar role in the pharmaceutical / biologics industry
  • Proven experience in writing and managing production deviations (end-to-end)

What we offer

  • Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
  • Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
  • International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

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